News & Analysis as of

Office of the Inspector General Clinical Laboratories

King & Spalding

OIG Releases Compliance Program Guidance Applicable to All Providers and Suppliers

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On November 6, 2023, OIG released new General Compliance Program Guidance (General CPG). The General CPG applies to all individuals and entities involved in the healthcare industry. The release of the General CPG was not...more

McDermott Will & Emery

OIG Pathology Lab: Don't Pay for Services You Don't Need

McDermott Will & Emery on

In September, the US Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion to a pathology laboratory concerning a proposed services arrangement with referring...more

Bass, Berry & Sims PLC

Labs Take Note: In a New Opinion, OIG Reminds Us that Fair Market Value Payments Can Still Violate the Anti-Kickback Statute

Bass, Berry & Sims PLC on

On September 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, in which it declined to approve an anatomic pathology laboratory’s proposal to purchase...more

Mintz - Health Care Viewpoints

OIG Issues Advisory Opinion Nixing Purchased Services Arrangement Between Certain Anatomic Pathology Laboratories

Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Epstein Becker & Green

The 2023 DOJ Health Care Fraud Enforcement (f/k/a “Takedown”): Big Dollars or Clever Packaging?

Epstein Becker & Green on

On June 28, 2023, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced a...more

Sheppard Mullin Richter & Hampton LLP

Laboratory and Pathology Information Blocking Concerns

Recently, we were invited to speak on a panel at the Executive War College on Diagnostics, Clinical Laboratory and Pathology Management. We spoke about the federal information blocking rules, and highlighted how some actors...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | December 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between November 21 and December 31, 2022, including recent enforcement activity and a summary of the Office of Inspector...more

K&L Gates LLP

COVID-19: A Roadmap to Fraud Investigations: Office of Inspector General Targets Labs for Billing COVID-19 Add-On Tests

K&L Gates LLP on

Introduction - On 6 December 2022, the Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a report (Report) that summarized findings of HHS-OIG’s review of laboratories with questionably high...more

Robinson+Cole Health Law Diagnosis

Suspect Characteristics Identified under a Telehealth Special Fraud Alert

HHS-OIG issued a new Special Fraud Alert on relationships with “purported telemedicine companies” on July 20, 2022. The Special Fraud Alert comes on the heels of a nationally coordinated takedown charging dozens of...more

McDermott Will & Emery

OIG Issues Unfavorable Opinion on Laboratory Specimen Collection Payments to Hospitals

McDermott Will & Emery on

OIG has a long history of scrutinizing laboratory arrangements because of the agency’s view that these arrangements are particularly susceptible to fraud and abuse. Much of OIG’s past guidance focused on laboratory...more

Venable LLP

Contractual Safeguards That Fall Short of a Safe Harbor

Venable LLP on

According to a recent Advisory Opinion from the Department of Health and Human Services (HHS) Office of Inspector General (OIG), a proposed fee arrangement could run afoul of the Federal anti-kickback statute, 42 USC...more

Bass, Berry & Sims PLC

OIG Declines to Approve Lab’s Payment of Specimen Collection Fees to Hospitals

On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more

Rivkin Radler LLP

DOJ Intervenes in Kickback Lawsuit Against Lab and Hospital Execs

Rivkin Radler LLP on

The U.S. Department of Justice (DOJ) recently intervened in an action filed in Texas against two laboratory CEOs, one hospital CEO, and numerous other executives, employees, and recruiters, seeking civil penalties and treble...more

Oberheiden P.C.

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

Oberheiden P.C. on

Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more

Womble Bond Dickinson

What to Expect as OIG and CMS Audits Focus on COVID-19 Testing?

Womble Bond Dickinson on

The COVID-19 pandemic has caused an enormous need for testing and has spawned the creation of new labs and specimen collection agencies to (try to) meet that need. In 2020 alone, Medicare spent $1.5 billion on COVID-19 tests....more

Oberheiden P.C.

5 Tips for Lab Compliance in 2023

Oberheiden P.C. on

In many ways, the COVID-19 pandemic increased the business opportunities available to clinical labs, including molecular and respiratory labs. As the nation—and the world—struggled to develop adequate testing infrastructure,...more

Oberheiden P.C.

Compliance Concerns for Respiratory and Clinical Labs Performing COVID-19 Testing

Oberheiden P.C. on

The tragedy of the COVID-19 pandemic is something we all agree we wish we could have avoided. However, the fact of the matter is that many respiratory and clinical labs have seen a boon to their bottom line due to the...more

Oberheiden P.C.

Key Elements of an OIG Compliance Program That Respiratory and Clinical Labs Need to Know

Oberheiden P.C. on

Clinical laboratories such as respiratory and clinical labs that bill Medicare, Department of Health and Human Services (“DHHS”) programs, and other federal programs are subject to oversight by the Office of Inspector General...more

Oberheiden P.C.

Eight Keys to Developing an OIG Compliance Program for Hospitals

Oberheiden P.C. on

The Office of Inspector General is a division of the U.S. Department of Health and Human Services that is tasked with combating fraud committed against Medicare, Medicaid, and other federally funded government programs. The...more

King & Spalding

HHS OIG Permits Labs to Offer Free COVID-19 Antibody Tests and Oncology Practices to Offer Free Lodging in Certain Circumstances

King & Spalding on

OIG has updated its FAQs regarding the application of its administrative enforcement authorities to arrangements directly connected with COVID-19 with the addition of two new FAQs. On August 4, 2020, the OIG issued an FAQ...more

Mintz - Health Care Viewpoints

All-Payor Kickback Statute Included in the Recently Passed Opioid Legislation Applies Broadly to Laboratories

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious...more

Baker Donelson

CMS Advisory Opinion 2017-01 Approves Pop-up Alerts to Physicians Through Online Laboratory Portal

Baker Donelson on

A clinical laboratory has received a green light from CMS to offer pop-up notifications alerting physicians of various potential issues (Laboratory Alerts) through its web-based portal for ordering and reporting results of...more

Parker Poe Adams & Bernstein LLP

OIG Releases 2017 Work Plan

On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) is charged with ensuring the integrity of more than 100 programs administered by DHHS, including...more

King & Spalding

OIG Raises Concerns Regarding Accuracy of New Clinical Laboratory Payment System

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On October 3, 2016, OIG released a report monitoring CMS’s progress on preparing for the implementation of the new payment system for clinical laboratory tests. The new payment system was mandated by the Protecting Access to...more

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